I. Introduction and Objective
When IDT Biologika GmbH (“IDT”) is involved with research funded by the Public Health Service of the U.S. Department of Health and Human Services (“PHS”), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (“NIH”), IDT must, and shall, comply with the requirements of 45 C.F.R. Part 94, “Responsible Prospective Contractors,” which promote objectivity in research and establish standards to provide a reasonable expectation that the design, conduct, and reporting of research performed under PHS contracts will be free from bias related to financial conflicts of interest.
The purpose of this Financial Conflict of Interest Policy (this “Policy”) is to establish the standards for compliance with 45 C.F.R. Part 94 and for determining the existence of conflicts of interest, the requirements for disclosing conflicts, and the process for reducing, managing, or eliminating conflicts.
II. Application
This Policy applies to all proposed and on-going PHS-funded research and any other research that IDT designates as subject to this Policy. Such PHS-funded research includes research authorized under the PHS Act (42 U.S.C. 201 et seq.) or other statutory authority, such as a research grant, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, conference and workshop grant, or research resources award.
III. Policy
A. Definitions.
Capitalized terms not otherwise defined herein shall have the meanings ascribed to such terms in 45 C.F.R. Part 94.
1. Contractor
means an entity that provides property or services under contract for the direct benefit or use of the U.S. Federal Government.
2. Financial conflict of interest (“FCOI”)
means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
3. FCOI report
means a report of a financial conflict of interest to a PHS awarding component.
4. Financial interest
means anything of monetary value, whether or not the value is readily ascertainable.
5. Institutional Responsibilities
means an Investigator’s professional responsibilities on behalf of IDT, which may include: research, research consultation, teaching, professional practice, and institutional committee memberships.
6. Investigator
means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
7. Key personnel
includes a project director or principal Investigator of a PHS-funded research project and any other personnel considered to be essential to work performance and identified as key personnel in the contract proposal and contract.
8. PHS Awarding Component
means the organizational unit of PHS that funds research subject to 45 C.F.R. Part 94.
9. Significant Financial Interest
means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
a) With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity (salary and any payment for services not otherwise identified as salary such as consulting fees, honoraria, or paid authorship) in the twelve (12) months preceding the disclosure aggregated with the value of any equity in the entity (for example, stock, stock options, or other ownership interests as determined through reference to public prices or other reasonable measures of fair market value) exceeds $5,000.
b) With regard to any non-publicly traded entity, a Significant Financial Interest exists if the aggregated value of any remuneration received from the entity in the twelve (12) months preceding the disclosure exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest.
c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
The term Significant Financial Interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by IDT to the Investigator if the Investigator is currently employed or otherwise appointed by IDT, including intellectual property rights assigned to IDT and agreements to share in royalties related to such rights; any ownership interest in IDT held by the Investigator; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
B. General Principles
1. IDT will fully comply with the federal rule at 45 C.F.R. Part 94 titled “Responsible Prospective Contractors,” as it relates to all Research, grants or awards for which funding from PHS or any PHS Awarding Component is sought or received (“PHS-funded research”).
2. The requirements of this Policy and the management of the processes necessary to implement this Policy are set forth in the following Procedures.
IV. Procedures
A. Investigator Disclosures
1. Project-Specific Disclosures.
IDT requires that each Investigator who is planning to participate in the PHS-funded research disclose to Thomas Picek the Investigator’s Significant Financial Interests related to the Investigator’s Institutional Responsibilities (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS-funded research.
2. Annual Disclosures.
IDT requires that each Investigator who is participating in the PHS-funded research submit an updated Disclosure of Significant Financial Interests form at least annually during the period of the award. Such disclosure shall include any information that was not disclosed initially to IDT or in a subsequent disclosure of Significant Financial Interests (e.g., any FCOI identified on a PHS-funded research project that was transferred from another institution), and shall include updated information regarding any previously disclosed Significant Financial Interest (e.g., the updated value of a previously disclosed equity interest).
3. Investigator Travel.
Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. This disclosure must include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
4. Disclosure Updates.
IDT requires that Investigators update IDT within thirty (30) days in the event that they discover or acquire a new Significant Financial Interest.
B. Review of Disclosures and Determination of FCOI
1. Review of Disclosures.
IDT is responsible for reviewing any disclosures of (i) Investigator Travel and/or (ii) a Significant Financial Interest belonging to an Investigator, and Investigator’s spouse, or the Investigator’s dependent children, to the extent either reasonably appear to relate to the Investigator’s Institutional Responsibilities (collectively, (i) and (ii) are included in the definition of “Significant Financial Interests”). IDT may, in its discretion, identify through procedures or other guidance documents, additional interests that it will review.
2. Relatedness Determination.
IDT will evaluate each disclosure to determine whether it relates to the Investigator’s Research or Institutional Responsibilities. A Significant Financial Interest will be found to relate to the Investigator’s Research or Institutional Responsibilities when it is reasonably determined that the Significant Financial Interest could be affected by the research, or is in an entity whose financial interest could be affected by the Research or Institutional Responsibilities. The Investigator may be asked to provide information to assist in the assessment of whether a Significant Financial Interest is related to the Investigator’s research or Institutional Responsibilities.
3. Timing of Review.
a) Initial Significant Financial Interests.
For PHS-funded research, Significant Financial Interests disclosed at the time of the funding and/or protocol application will be evaluated prior to the expenditure of any funds. For all other research subject to this Policy, Significant Financial Interests disclosed at the time of the funding and/or protocol application will be evaluated prior to the initiation of the research activities.
b) Updated Significant Financial Interests.
To the extent a new Significant Financial Interest is disclosed to IDT in the course of an ongoing research project, IDT will, within sixty (60) days from the date of the disclosure: (i) determine if the Significant Financial Interest relates to the Investigator’s research; (ii) if it relates, determine if it qualifies as an FCOI; and (iii) if it is an FCOI, implement on at least an interim basis a management plan as described below. IDT may, depending on the circumstances, conclude that additional interim measures are necessary with regard to the Investigator’s participation in the research between the date of disclosure and the completion of IDT’s review.
4. Determination of FCOI.
An FCOI will be found to exist when a Significant Financial Interest related to the Investigator’s research could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. IDT will maintain a process and written criteria for making FCOI determinations, and will evaluate and revise such guidelines as appropriate.
C. Management of FCOI
1. Management of FCOI.
For any identified FCOI, IDT shall take appropriate action to manage the conflict in order to reduce the potential for it to compromise the safety or validity of the research. Research in which an Investigator is found to have an FCOI will not be permitted to proceed until the Investigator has agreed to implement an acceptable management plan. The appropriate techniques identified by IDT to manage an identified FCOI will be outlined in a written management plan. Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:
a) With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity (salary and any payment for services not otherwise identified as sa) Public disclosure of the FCOI (e.g., when presenting or publishing the research).
b) For research involving human subjects, disclosure of the FCOI directly to participants.
c) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI.
d) Modification of the research plan.
e) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research.
f) Reduction or elimination of the financial interest (e.g., sale of an equity interest).
g) Severance of relationships that create FCOI.
2. Disclosure for PHS-Funded Drug/Device Research.
In any case in which the U.S. Department of Health and Human Services determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by IDT, the Investigator will be required to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
D. Retrospective Reviews; Mitigation Reports
1. Identification of Significant Financial Interests Not Timely Disclosed or Reviewed.
In the event IDT identifies a Significant Financial Interest that was not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed by IDT in accordance with this Policy during an on-going research project (e.g., was not timely reviewed or reported by a subrecipient), IDT will, within sixty (60) days of identifying such a Significant Financial Interest: (i) determine if the Significant Financial relates to the Investigator’s research; (ii) if it relates, determine if it qualifies as an FCOI; and (iii) if it is an FCOI, implement on at least an interim basis a management plan in accordance this Policy to manage the FCOI going forward. Depending on the nature of the FCOI, if a retrospective review for bias is required, IDT may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research between the date that the FCOI is determined and the completion of IDT’s retrospective review. The identified FCOI must be reported to the relevant PHS Awarding Component in accordance with this Policy.
2. Retrospective Review for Bias.
There may be times when an FCOI is not identified or managed in a timely manner, including: failure by the Investigator to disclose a Significant Financial Interest that is determined by IDT to constitute an FCOI; failure by IDT to review or manage such an FCOI; or failure by the Investigator to comply with an FCOI management plan. In the event such noncompliance is identified, IDT will, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities and the research to determine whether there was any bias in the design, conduct or reporting of the research or any portion thereof during the time period of the noncompliance. Any FCOI report submitted with respect to such research will be updated as necessary in light of the results of the retrospective review.
3. Documentation of Retrospective Review.
IDT will document the following with regard to any retrospective review:
a) Project number.
b) Project title.
c) Project director (PD)/principal investigator (PI) or contact PD/PI if a multiple PD/PI model is used.
d) Name of the Investigator with the FCOI.
e) Name of the entity with which the Investigator has the FCOI.
f) Reason(s) for the retrospective review.
g) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed).
h) Findings of the review.
i) Conclusions of the review.
4. Notification of Awarding Agency; Mitigation Report.
If bias is found in the design, conduct or reporting of PHS-funded research during the period of noncompliance, IDT will promptly notify the relevant PHS Awarding Component and will submit a mitigation report, which will include at least the elements documented in the retrospective review and a description of the impact of the bias on the research project IDT’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
E. IDT Notification and Reporting to PHS Awarding Agencies
1. PHS Notification.
For PHS-funded research, IDT will provide all required notifications and reports to the relevant PHS Awarding Component, in accordance with applicable regulations and this Policy.1
2. FCOI Reports.
a) Types of FCOI Reports.
IDT will report any identified FCOI that is related to PHS-funded research to the relevant PHS awarding agency, whether identified in advance of commencing a PHS-funded research project (an “Initial FCOI Report”) or in the course of an on-going PHS-funded research project as a result of new FCOI information (“Updated FCOI Report”). For any identified FCOI related to on-going PHS-funded research that was previously reported in an Initial FCOI Report, IDT will provide an annual FCOI report that addresses the status of the FCOI (including any changes in the value of the previously reported interest) and any changes to the management plan (“Annual FCOI Report”). Such Annual FCOI Reports will be provided for the duration of the PHS-funded research.
b) Timing of FCOI Reports.
IDT will provide required FCOI reports in accordance with the following timeframes:
a) Project number.
b) Project title.
c) Project director (PD)/principal investigator (PI) or contact PD/PI if a multiple PD/PI model is used.
d) Name of the Investigator with the FCOI.
e) Name of the entity with which the Investigator has the FCOI.
f) Reason(s) for the retrospective review.
g) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed).
h) Findings of the review.
i) Conclusions of the review.
(i) Initial FCOI Reports: prior to the expenditure of any funds.
(ii) Updated FCOI Reports: within sixty (60) days of identification of a new FCOI (whether due to a new Investigator or a new FCOI disclosed by an existing Investigator) or identification of an FCOI that was not timely disclosed or managed.
(iii) Annual FCOI Reports: at least annually, in accordance with the awarding agency’s specifications. For NIH-funded research, the Annual FCOI Report is due at the same time as IDT is required to submit the annual progress report for a grant, including a multiyear funded progress report if applicable, or at the time of the extension.
c) Content of FCOI Reports.
Any FCOI Report shall provide sufficient information to enable the PHS awarding agency to understand the nature and extent of the FCOI and to assess the appropriateness of IDT’s management plan. Any FCOI Report will include at least the following information:
(i) Project number.
(ii) Project Director/Principal Investigator (“PD/PI”) or contact PD/PI if a multiple-PD/PI model is used.
(iii) Name of the Investigator with the FCOI.
(iv) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium).
(v) Value of the financial interest, provided in dollar ranges, or a statement that the interest is one whose value cannot be readily determined through reference to pubic prices or other reasonable measures of fair market value.
(vi) A description of how the financial interest relates to the PHS-funded research and the basis for IDT’s determination that the financial interest conflicts with such research.
(vii) A description of the key elements of IDT’s management plan, including: the role and principal duties of the conflicted Investigator in the research; the conditions of the management plan; how the management plan is designed to safeguard objectivity in the research; confirmation of the Investigator’s agreement to the management plan; how the management plan will be monitored to ensure Investigator compliance; and any other information IDT deems necessary to meet its obligations under applicable regulations and this Policy.
d) Additional Notifications.
In addition to the required FCOI reports, IDT will promptly notify the relevant PHS Awarding Component in the event that it finds that an Investigator’s failure to comply with this Policy or an imposed management plan has biased the design, conduct, or reporting of PHS-funded research (such notification will include the corrective action taken or to be taken in response to the identified Investigator non-compliance).
F. Requirements for Subrecipients of PHS-Funded Research
If IDT carries out the PHS-funded research through a subrecipient (e.g., subcontractors, or consortium members), IDT (the awardee Institution) must take reasonable steps to ensure that any subrecipient Investigator complies with this part by:
1) Incorporating as part of a written agreement with the subrecipient terms that establish whether IDT’s FCOI Policy or the subrecipient’s FCOI policy will apply to the subrecipient’s Investigators.
a) If the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with 45 C.F.R. Part 94. If the subrecipient cannot provide this certification, the subrecipient’s Investigators will be subject to the requirements of this Policy for disclosing Significant Financial Interests that are directly related to the subrecipient’s work for IDT.
b) Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the agreement with the subrecipient shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to IDT. Such time period(s) shall be sufficient to enable IDT to comply with this Policy and to provide timely FCOI reports, as necessary, to the PHS or the PHS Awarding Component.
c) Alternatively, if the subrecipient’s Investigators must comply with IDT’s FCOI Policy, the agreement with the subrecipient shall specify time period(s) for the subrecipient to submit all Investigator disclosures of Significant Financial Interests to IDT. Such time period(s) shall be sufficient to enable IDT to comply timely with its review, management, and reporting obligations as set forth in this Policy and in 45 C.F.R. Part 94.
2) Providing timely FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators (i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI).
V. Notice and Training
A) Notice.
IDT shall provide all Investigators with notice of this Policy, the Investigator’s responsibilities regarding disclosure of Significant Financial Interests and of the regulations in 45 C.F.R. Part 94.
B) Training Requirement.
All Investigators must receive training on this Policy prior to engaging in Research related to any PHS-funded contract.
C) Training Frequency. Investigators must complete training at least every four years following the initial training. In addition, Investigators must receive training immediately in any of the following circumstances:
1. IDT revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
2. An Investigator is new to IDT; or
3. IDT finds that an Investigator is not in compliance with this Policy or a management plan.
VI. Non-Compliance and Disciplinary Action
A) Compliance Expectation
Individuals subject to this Policy are expected and required to comply fully and promptly with the requirements of this Policy.
B) Disciplinary Action
Investigators who deliberately or repeatedly fail to fully and truthfully disclose Significant Financial Interests, or fail to comply with any Management Plan, shall be subject to disciplinary action, up to and including termination.
VII. Public Access
Prior to expenditure of any funds under a PHS-funded research project, IDT will ensure public access, via IDT’s publicly accessible website , to this Policy. Prior to expenditure of any funds under a PHS-funded research project, IDT will ensure public access, via IDT’s publicly accessible website or written response to any requestor within five (5) business days of a request, to the following information concerning any FCOI involving Key Personnel that is still held by Key Personnel:
The Investigator’s name;
The Investigator’s title and role with respect to the research project;
The name of the entity in which the Significant Financial Interest is held;
The nature of the Significant Financial Interest that forms the basis of the FCOI
The approximate dollar value of the significant financial interest provided in dollar ranges, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
VIII. Record Retention
IDT will maintain records relating to all Investigator disclosures of financial interests and IDT’s review of, and response to, such disclosures (whether or not a disclosure resulted in a determination of an FCOI), and all actions under this Policy or retrospective review, if applicable, for at least three years from the date of final payment by PHS.
RESPONSIBILITY FOR MAINTENANCE OF THIS POLICY: Director Global Treasury
RESPONSIBILITY FOR OVERSIGHT AND REVIEW: Director Global Treasury
REVIEW AND APPROVAL DATE: June 02, 2017
APPROVED BY: Andreas Kastenbauer, Dr. Christian Wirth, Chief Executive Officers
1 To the extent that a U.S. government contract requires notice to be provided to the Contracting Officer assigned to the contract, then notice shall be provided to both the assigned Contracting Officer and the PHS Awarding Component. Such notification requirement, where applicable, relates to all notification and reporting obligations addressed in this Policy.